A Clinical Trial to Investigate the Efficacy of BioCopper1®, Restore Cu1, and Grow + Restore Cu1 on Hair and Skin Improvements in Healthy Adults

MitoSynergy

Status: Not yet enrolling

Conditions: Grey Hair; Hair Growth; Skin Health

Treatments: Dietary Supplement: Grow + Restore Cu1; Dietary Supplement: Placebo; Dietary Supplement: Restore Cu1; Dietary Supplement: BioCopper1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07839494

26MSKGC01

Details and patient eligibility

About

The goal of this clinical trial is to investigate the efficacy of BioCopper1®, Restore Cu1, and Grow + Restore Cu1 on grey hair, hair growth, and/or skin improvements in healthy adults. The main question it aims to answer is: what is the change from baseline to Day 168 in percentage of grey hair between BioCopper1®, Restore Cu1, or Grow + Restore Cu1 and placebo, as assessed by HairMetrix? Researchers will compare the investigational products to a placebo to determine their effectiveness. Participants will be asked to:

• Have their blood pressure, heart rate, height, and weight measurements taken
• Have their blood samples collected
• Complete questionnaires and a study diary
• Be assessed using the VISIA imaging system, Corneometer, and Cutometer
• Consume BioCopper1®, Restore Cu1, Grow + Restore Cu1, or placebo

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males and females aged 18 to 45 years, inclusive

2. Stable body weight defined as a <5% change in body weight in the three months prior to baseline as assessed by the Qualified Investigator (QI)

3. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals of child-bearing potential must have a negative baseline A urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

   • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Nexplanon)
   • Double-barrier method
   • Intrauterine devices
   • Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
   • Vasectomy of partner at least 6 months prior to screening
   • Abstinence and agrees to use contraception if planning on becoming sexually active during the study

4. Visual confirmation of ≥ 5% and ≤ 20% of grey hair at screening

5. Pattern hair loss (Savin/Ludwig Scale Criteria I-2 (early-moderate hair loss) to II-2 (moderate hair loss) for females and Hamilton-Norwood Scale Criteria II to IV-A for males) at screening as assessed by the QI (onset of hair loss/thinning not to correspond with hormonal birth control or other recent onset of new medications, as assessed by the QI)

6. Agrees to maintain normal hair cleaning (frequency and use of non-medicated shampoo and/or conditioner) and general hair regime for the study period (including use of heated hair tools)

7. Agrees to maintain hairstyle for the study period

8. Agrees to avoid colouring hair 6 weeks prior to screening/baseline and each clinic visit

9. Agrees to maintain normal skin care routine for the study period and avoid use of cosmetic products (e.g, cleansing products, creams, makeup) on the day of clinic visits

10. Agrees to avoid excessive sun exposure and engage in safe sun practices for the duration of the study period

11. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study

12. Provided voluntary, written, informed consent to participate in the study

13. Healthy as determined by medical history and laboratory results as assessed by the QI

Exclusion criteria

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Allergy, sensitivity, or intolerance preventing consumption of investigational product, comparator, or placebo ingredients
3. Infections or dermatological conditions of the scalp and/or face
4. Significant life or traumatic event that may be associated with acute hair loss (e.g., postpartum, job loss, death of a family member), as assessed by a QI
5. Current diagnosis or history of Lyme disease
6. History of or current diseases (e.g., alopecia areata) or conditions (e.g., trichotillomania, telogen effluvium, polycystic ovary syndrome) contributing to hair loss or thinning
7. Use of hair treatments, medications, or therapies for the purpose of regrowing and/or thickening (e.g., scalp treatments, hair transplantation surgery), as assessed by the QI
8. Individuals with hair extensions or planning on getting hair extensions during the study period, as assessed by the QI
9. Individuals with known disorders of copper metabolism (e.g., Wilson disease)
10. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
11. Unstable metabolic disease or chronic diseases as assessed by the QI
12. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
13. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
14. Type I or Type II diabetes
15. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
16. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
17. Current diagnosis with biliary disorders
18. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
19. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
20. Individuals with an autoimmune disease or are immune compromised as assessed by the QI
21. Self-reported confirmation of a Human Immunodeficiency Virus (HIV)-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
22. Self-reported confirmation of blood/bleeding disorders as assessed by the QI
23. Use of prescribed cannabinoid products as assessed by the QI
24. Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
25. Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
26. Alcohol intake average of >2 standard drinks per day as assessed by the QI
27. Alcohol or drug abuse within the last 12 months
28. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3)
29. Clinically significant abnormal laboratory results at screening as assessed by the QI
30. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
31. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
32. Individuals who are unable to give informed consent
33. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

88 participants in 4 patient groups, including a placebo group

BioCopper1

Experimental group

Description:

Starting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.

Treatment:

Dietary Supplement: BioCopper1

Restore Cu1

Experimental group

Description:

Starting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.

Treatment:

Dietary Supplement: Restore Cu1

Grow + Restore Cu1

Experimental group

Description:

Starting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.

Treatment:

Dietary Supplement: Grow + Restore Cu1

Placebo

Placebo Comparator group

Description:

Starting the day following their baseline B visit (Day 1), participants will be instructed to take one dose (one capsule) with water twice daily with food until the day prior to their end of study visit (Day 167). Participants will be instructed to not take any zinc or N-acetylcysteine supplements within 4 hours of dose.

Treatment:

Dietary Supplement: Placebo